Director, Operations - Drug Product (Biologics)

Merck seeks a Director of Operations for Drug Product to lead biologics manufacturing at a new high-potency facility in Wilmington, Delaware. The role involves overseeing GMP production of advanced therapeutics, managing cross-functional teams, and ensuring regulatory compliance and operational excellence during facility start-up and commercial production.

Responsibilities

• Lead drug product operations for commercial and new product manufacturing at the Wilmington facility
• Oversee facility start-up and production of high-potency products including antibody drug conjugates
• Manage cross-functional teams through technology transfers and commercial approvals
• Drive operational and technical excellence, implement Lean principles, and maintain inspection readiness
• Monitor departmental KPIs including hiring, uptime, training, yield, and production cadence

Requirements

• Bachelor's degree in engineering/science plus 12 years industry experience (or Master's plus 10 years, or PhD plus 8 years)
• 6+ years demonstrated leadership managing and mentoring cross-functional teams
• Experience in biotech/pharma manufacturing with sterile drug product focus
• Clinical and commercial manufacturing product experience
• Knowledge of cGMP requirements for high-potency ADC drug product manufacturing
• Lean manufacturing and process optimization expertise
• Data analysis, regulatory compliance, and quality management systems proficiency